Systems Engineer II

Tandem Diabetes Care

1d • Hybrid

About The Position

The Systems Engineer II supports system engineering activities for new and existing product development initiatives, with a focus on mobile applications. This role works cross-functionally to contribute to the definition, design, and development of Tandem products, enabling end to end clinical and non clinical customer workflows across the product lifecycle. Responsibilities include designing system-level solutions for mobile application releases, with an emphasis on globalization of mobile applications. Under the guidance of systems engineering leadership, the Systems Engineer II defines system-level requirements, interface specifications, and subsystem designs in collaboration with internal stakeholders.

Requirements

• Bachelor of Science or equivalent degree in System Engineering, Electrical Engineering, Mechanical Engineering, Computer Science or Biomedical Engineering required, or equivalent combination of education and applicable job experience.
• 2+ years’ experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment.
• 2+ years’ experience working in a regulated industry; Medical Device industry preferred.
• Demonstrated capability in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, system failure modes and adversarial scenario analysis.
• Ability to work and deliver a high-quality work product with mentoring.
• Ability to effectively convey information related to work product and lead review discussions.
• Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Nice To Haves

• Advanced coursework, master’s degree, or professional licensing in related field desirable.
• Experience with requirements management systems (e.g., JAMA, DNG), highly desirable.
• Familiarity with one or more of the following: ISO 13845, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls, HIPAA and/or GDPR, preferred.

Responsibilities

• Develops, documents, maintains, and communicates system and subsystem requirements and design, in coordination with various stakeholders such as Engineering, Product Management, Cybersecurity, Information Technology and Quality Assurance with globalization mindset.
• Provides system expertise to support on-market-products technical support troubleshooting, failure analysis, and triage of system level issues.
• Contributes to the development and maintenance of inter-system interface specifications and contracts, considering cross-subsystem impacts.
• Contributes to the risk management process and derives risk mitigation requirements.
• Maintains tight collaboration with the teams responsible for product V&V, reviews test plans and protocols, and helps triage issues uncovered during testing activities.
• Works closely with the SW and HW development teams to flow down the system and subsystem requirements and assist with establishing traceability.
• Traces system and subsystem requirements to the user and business needs defined for the product.

Benefits

• medical
• dental
• vision
• health savings accounts
• flexible saving accounts
• 11 paid holidays per year
• a minimum of 20 days of paid time off (with accrual starting on day 1)
• 401k plan with company match
• Employee Stock Purchase plan

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level